Short and Long-arm Fiberglass Cast Immobilization for Distal Salter Harris I and II Forearm Fractures in Children

Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen im Kindesalter

The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients.

Study Overview

• Status: Recruiting
• Conditions: Fracture Forearm
• Intervention / Treatment: Device: short-arm fiberglass cast; Device: long-arm fiberglass cast

Detailed Description

The patients are allocated randomly into the two groups(short-arm cast, long-arm cast). After confirming study participation, patients draw a sealed envelope enclosing a numbered card, which assignes them to one group or other. After choosing the envelope, neither the ED staff nor the parents and their childrenare blinded for the treatment groups. However, the data are going to be analyzed under blinded conditions

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Seiler, PD; Phone Number: +41 44 266 43 10; Email: michelle.seiler@kispi.uzh.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • Recruiting
    • University Children's Hospital Zurich
    • Contact: Michelle Seiler, MD; Phone Number: +41 44 266 32 10; Email: michelle.seiler@kispi.uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Salter Harris I or II fracture of the distal radius or a forearm fracture
• informed consent

Exclusion Criteria:

• open/instable/intraarticular fracture
• age <4 years or > 16years
• no informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: short-arm fiberglass cast; salter harris fractures of the distal radius/forearm in children are usually treated with fiberglass long-arm casts. The investigators were able to demonstrate that in distal metaphyseal forearm fracture, treatment with a short-arm cast is not inferior to a long-arm cast. Patients are going to receive a short-arm cast for fracture treatment.	Device: short-arm fiberglass cast; fracture stabilization of salter harris I/II fractures with a fiberglass short-arm cast
Active Comparator: long-arm fiberglass cast; salter harris fractures of the distal radius/forearm in children are usually treated with a fiberglass long-arm cast. Patients are going to receive a long-arm cast for fracture treatment.	Device: long-arm fiberglass cast; fracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of fracture displacement	difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)	in the first four weeks after trauma

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Study Chair: Michelle Seiler, PD, University Children's hospital, Zürich

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: UChildrenZurich_salter harris

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No